Senior Specialist, Quality Assurance (Process Support)

Responsibilities

• Review and approve the Validation Master Plan (VMP), process validation protocols (including Process Performance Qualification and supporting studies), ensuring alignment with cGMP requirements, applicable regulatory standards, Lonza policies and procedures, and customer expectations.
• Provide QA oversight during validation execution to ensure strict adherence to approved protocols and standard operating procedures (SOPs).
• Review and approve discrepancies and deviations arising during validation activities; ensure thorough investigation, robust root cause analysis, and appropriate assessment of impact on validation status. Oversee approval and timely closure of associated Corrective and Preventive Actions (CAPAs).
• Review and approve validation reports, confirming that all acceptance criteria are met, deviations are adequately resolved or justified, and conclusions are data-driven and fully compliant with regulatory expectations.
• Review and approve Continued Process Verification (CPV) protocols and reports to ensure ongoing assurance of process performance and product quality.

Requirements

• Degree in Biological Science / Engineering and experience in Validation / Quality unit in the Biopharmaceutical industry .
• 5-8 years of experience in a similar type of industr y or a similar job role.
• Able to operate independently with minimum supervision.
• Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
• Team player, with strong focus on safety, quality and timelines
• About Lonza
• Ready to shape the future of life sciences?

Benefits

Additional Information

As a Senior QA Specialist, you will support and p rovide Quality oversight for engineering and validation activities. This is a fully site‑based role at Singapore Tuas. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. What you'll get An agile career and dynamic working culture in a global life sciences leader. An inclusive and ethical workplace that values diversity and integrity. Competitive compensation programs that recognize high performance. Professional growth opportunities through cross-functional projects and global exposure. Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums. Company transport provided from designated MRT locations to and from the Tuas site. Access to Lonza's full suite of employee benefits: www.lonza.com/careers/benefits

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